ELECSYS FT3 III

Additional Manufacturer Narrative

THE INVESTIGATION TESTED THE PATIENT SAMPLE USING TWO VERSIONS OF FT3 III ON BOTH THE E411 AND E801 ANALYZERS; NO SIGNIFICANT DIFFERENCE WAS FOUND BETWEEN THE CUSTOMER'S AND THE INVESTIGATION'S RESULTS. THE INVESTIGATION TESTED THE PATIENT SAMPLE FOR THE PRESENCE OF AN INTERFERENT USING RESEARCH TOOLBOXES; AN ASSAY INTERFERING FACTOR WAS DETECTED BY CHANGING CONCENTRATIONS. THE INVESTIGATION DETERMINED THE EVENT WAS CAUSED BY AN INTERFERENT IN THE PATIENT SAMPLE. PRODUCT LABELING STATES "IN RARE CASES, INTERFERENCE DUE TO EXTREMELY HIGH TITERS OF ANTIBODIES TO ANALYTE-SPECIFIC ANTIBODIES, STREPTAVIDIN OR RUTHENIUM CAN OCCUR. THESE EFFECTS ARE MINIMIZED BY SUITABLE TEST DESIGN. FOR DIAGNOSTIC PURPOSES, THE RESULTS SHOULD ALWAYS BE ASSESSED IN CONJUNCTION WITH THE PATIENT¿S MEDICAL HISTORY, CLINICAL EXAMINATION, AND OTHER FINDINGS." THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE COBAS 8000 E 801 MSB/MSBL IS (B)(6) . THE PATIENT SAMPLE WAS RECEIVED FOR INVESTIGATION. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS FT3 III (FT3 III) AND ELECSYS FT3 III VER. 2 (FT3 III V 2) RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE COBAS 8000 E 801 MSB/MSBL. THE REPORTER SUSPECTS THE INITIAL RESULT WAS A FALSE POSITIVE CAUSED BY AN INTERFERENCE IN THE PATIENT SAMPLE. THIS MDR IS FOR THE FT3 III ASSAY. PLEASE REFER TO MEDWATCH WITH A1. PATIENT IDENTIFIER PT (B)(6) FOR THE FT3 III V 2 ASSAY PLEASE REFER TO THE ATTACHMENT PT (B)(6) FOR THE TABLE CONTAINING THE HIGHLIGHTED QUESTIONABLE RESULTS.